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Norm
ÖNORM EN 592
Issue date: 2002 05 01
Instructions for use for in vitro diagnostic instruments for self-testing
This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-...
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Withdrawn
: 2010 04 15
Publisher:
Austrian Standards International
Format:
Digital | 11 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.
NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.
NOTE 2 This standard can also be applied to accessories.
This standard is not applicable to field repair instructions.
ÖNORM EN ISO 18113-5
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5:...
Norm
ÖNORM EN ISO 18113-5
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5:...
Norm
ÖNORM EN 592
2002 05 01
Instructions for use for in vitro diagnostic instruments for self-testing
Norm
↖
ÖNORM EN 592
1995 01 01
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for ...
Norm
Norm
ISO 1000:1992
Issue date :
1992 11 12
SI units and recommendations for the use of their multiples and of certain other units
Norm
ÖNORM EN ISO 18113-5
Issue date :
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)